Baricitinib Well-Tolerated in Atopic Dermatitis for Several Adverse Events

Baricitinib appears to be well-tolerated among adult patients treated for moderate-to-severe atopic dermatitis (AD), according to study findings published in Dermatitis.

Researchers conducted an observational study using pooled data from placebo-controlled and long-term extensions in the baricitinib AD clinical trial program (ClinicalTrials.gov Identifier: NCT02576938; NCT03334396; NCT03334422; NCT03428100; NCT03435081; NCT03733301; NCT03334435; NCT03559270) that included 2531 patients treated with baricitinib 1 mg (n=1466), 2 mg (n=576), and 4 mg (n=489). A total of 6 studies were double-blinded randomized placebo-controlled, 1 study was a double-blinded randomized long-term extension, and 1 study was an open-label long-term extension.

Participants were aged 18 years and older with moderate-to-severe AD. Overall, 39.3% of the participants were women with 14.9 years since diagnosis, and of whom 89.1% received topical corticosteroids prior to the study. Patients with concomitant skin conditions that could affect assessment of AD lesions, a venous thromboembolic event (VTE) or major cardiovascular event within 12 weeks of screening, those at high risk for VTE, or those with a history of eczema herpeticum within 12 months before screening were excluded from the final analysis.

Most adverse events (AEs) were mild-to-moderate in severity. Headache was the most common AE. Median AE onset was 14 to 26 days after first dose of baricitinib in placebo-controlled trials to week 16 with a median duration of 3 days. Headaches were reported as mild to moderate in the 16-week studies and for baricitinib 2 mg in the extended studies. Headaches included reports of mild, moderate, and severe for both baricitinib 1 mg and 4 mg in the extended studies.

Acne incidence was reported in 15 participants receiving baricitinib 2 mg and in 17 participants receiving baricitinib 4 mg in the extended studies and in 74 participants receiving the overall combined doses. All AEs were mild and moderate with a median duration of 53 to 90 days in the baricitinib 2 mg and 4 mg doses and over 82 days in those who received the overall combined doses.

Examined as individual events, diarrhea (median duration, 3.0-4.5 days), abdominal pain (median duration, 3.0-5.0 days), abdominal pain upper (median duration, 3.0-11.0 days), abdominal pain lower (median duration, 0.0-13.5 days), nausea (median duration, 3.0-6.5 days), vomiting (median duration, 2.0-3.0 days), and constipation (median duration, 1.0-135.5 days) each had relatively low incidence rates. There were 5 permanent discontinuations for tolerability AEs and 6 study medication interruptions.

Limitations of the study include the nature of the observational study design and the varying quality of reporting safety events, including coding and terminology of AE issues.

Researchers conclude, “Overall, the frequency of AEs related to tolerability for baricitinib in patients being treated for moderate-to-severe AD was low. Based on the entirety of the baricitinib safety data, headache, nausea, abdominal pain, and acne are considered adverse drug reactions.”

Disclosure: This research was supported by Eli Lilly and Company.

Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.